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临床试验/NCT05681611
NCT05681611已完成不适用

Correlation Between Trend of Four Values and Bispectral Index Values During General Anaesthesia for Breast Surgery.

University of Padova1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年3月3日最近更新:
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试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Correlation between Trend of Four (TOF) and Bispectral Index (BIS) values

研究概览

简要总结

Aim of this trial is to define if Trend of Four (TOF) values after a bolus of rocuronium is correlated with Bispectral Index BIS values during standard general anaesthesia for breast surgery.

详细描述

Rocuronium. a curarizing agent, has been shown to decrease Bispectral Index (BIS) in awake volunteers.

However, correlation between Trend of Four (TOF) values after a bolus of rocuronium and BIS values during general anaesthesia for breast surgery has not been defined yet.

Investigators want to analyze this correlation during general anaesthesia conducted using Propofol and remifentanil. All of these drugs will be delivered with Targeted-Controlled Infusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil), commonly used to deliver general anaesthesia. At stable anaesthesia maintenance, if requested for surgical (ie more muscle relaxation) or anesthesiological reasons (i.e. avoid air insufflation) a standard Rocuronium bolus (0.6 mg/kg) was given. In these case, with rocuronium bolus justified by clinical reasons, authors will observationally record the BIS values and the TOF values.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergo General Anaesthesia with Propofol and Remifentanil, and necessity of curarization with Rocuronium for surgical or ventilatory reasons.

排除标准

  • Neurological disease
  • Psychiatric disease
  • Benzodiazepines praemedication

结局指标

主要结局

Correlation between Trend of Four (TOF) and Bispectral Index (BIS) values

时间窗: 60 minutes after rocuronium bolus

Discover if there is linear correlation between TOF values (utilized for curarization monitoring) and BIS values (utilized for deep of hypnosis monitoring) during standard general anaesthesia conducted with Propofol and remifentanil with targeted controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia

次要结局

未报告次要终点

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Linassi

MD. Anaesthesiologist at Treviso Regional Hospital

University of Padova

研究点 (1)

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